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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 53487

21 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 17, 2009
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Spinal Elements, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

21 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 21

Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1246-2013
Recall number
Z-1246-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080582

Distribution pattern

Distributed in OH and PA.

device · product 2 of 21

Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1247-2013
Recall number
Z-1247-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080583

Distribution pattern

Distributed in OH and PA.

device · product 3 of 21

Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1248-2013
Recall number
Z-1248-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080584

Distribution pattern

Distributed in OH and PA.

device · product 4 of 21

Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1249-2013
Recall number
Z-1249-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080585

Distribution pattern

Distributed in OH and PA.

device · product 5 of 21

Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1250-2013
Recall number
Z-1250-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot number: 080586

Distribution pattern

Distributed in OH and PA.

device · product 6 of 21

Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1251-2013
Recall number
Z-1251-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot number: 080587

Distribution pattern

Distributed in OH and PA.

device · product 7 of 21

Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1252-2013
Recall number
Z-1252-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080588

Distribution pattern

Distributed in OH and PA.

device · product 8 of 21

Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1253-2013
Recall number
Z-1253-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080589

Distribution pattern

Distributed in OH and PA.

device · product 9 of 21

Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1254-2013
Recall number
Z-1254-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot number: 080590

Distribution pattern

Distributed in OH and PA.

device · product 10 of 21

Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1255-2013
Recall number
Z-1255-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080591

Distribution pattern

Distributed in OH and PA.

device · product 11 of 21

Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1256-2013
Recall number
Z-1256-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot number: 080592

Distribution pattern

Distributed in OH and PA.

device · product 12 of 21

Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1257-2013
Recall number
Z-1257-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080593

Distribution pattern

Distributed in OH and PA.

device · product 13 of 21

Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1258-2013
Recall number
Z-1258-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080594

Distribution pattern

Distributed in OH and PA.

device · product 14 of 21

Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1259-2013
Recall number
Z-1259-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080594

Distribution pattern

Distributed in OH and PA.

device · product 15 of 21

Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1260-2013
Recall number
Z-1260-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080596

Distribution pattern

Distributed in OH and PA.

device · product 16 of 21

Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1261-2013
Recall number
Z-1261-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080597

Distribution pattern

Distributed in OH and PA.

device · product 17 of 21

Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1262-2013
Recall number
Z-1262-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080598

Distribution pattern

Distributed in OH and PA.

device · product 18 of 21

Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1263-2013
Recall number
Z-1263-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080599

Distribution pattern

Distributed in OH and PA.

device · product 19 of 21

Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1264-2013
Recall number
Z-1264-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080600

Distribution pattern

Distributed in OH and PA.

device · product 20 of 21

Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1265-2013
Recall number
Z-1265-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080601

Distribution pattern

Distributed in OH and PA.

device · product 21 of 21

Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Z-1266-2013
Recall number
Z-1266-2013
Initiated
April 17, 2009
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
68 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Code information

Lot Number: 080602

Distribution pattern

Distributed in OH and PA.